A Study of Macitentan and Tadalafil as a Fixed Dose Combination and the Free Combination in Healthy Adult Participants

Summary

The purpose of this study is to demonstrate bioequivalence on the primary pharmacokinetic (PK) parameters of tadalafil administered as an fixed dose combination (FDC) (test) of macitentan/tadalafil (10 milligram \[mg\]/40 mg) and coadministered as a free combination (reference) of 10 mg macitentan (Opsumit) and 40 mg Canada-sourced tadalafil (Adcirca) in fasted conditions in healthy adult participants (Group 1) and to evaluate the effect of food on the primary PK parameters of macitentan and tadalafil administered as an FDC of macitentan/tadalafil (10 mg/40 mg) in healthy adult participants (Group 2).

Timeline

Start

2020-01-17

Primary completion

2020-07-17

Completion

2020-07-17

Publications

• Csonka D, Fishman V, Natarajan J, Stieltjes H, Armas D, Dishy V, Perez Ruixo JJ. Bioequivalence and food effect of a fixed-dose combination of macitentan and tadalafil: Adaptive design in the COVID-19 pandemic. Pharmacol Res Perspect. 2021 Oct;9(5):e00846. doi: 10.1002/prp2.846.

Drugs

Indications

No indication recorded.